Past Meetings

The committees will discuss new drug application (NDA) 203324, for riboflavin ophthalmic solutions with UV-A irradiation, submitted by Avedro, Inc. The combination products are used in corneal collagen cross-linking and proposed to be indicated for the treatment of progressive keratoconus or corneal ectasia following refractive surgery.

The committee will discuss biologics license application (BLA) 125504, secukinumab, a human monoclonal antibody, submitted by Novartis, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

The committee will be asked to comment on the following topics related to the
use of ophthalmic drug products (products intended for use in the eye): 1) Appropriate types of
clinical evidence for developing anti-inflammatory drugs for the treatment of postoperative
inflammation and reduction of ocular (eye) pain in patients who have undergone ocular surgery.
This will include a discussion of the definition and scope of this indication as well as the types of
clinical trials needed to support approval; and 2) appropriateness of marketing a single bottle of
3
ophthalmic product for use in both eyes for postsurgical indications as it relates to the potential
risk for infection. FDA's Center for Drug Evaluation and Research would like the advisory
committee to provide advice on the potential risk and approaches to mitigating that risk,
including limits to fill size where appropriate.

On June 28, 2010, the committee will discuss new drug application (NDA) 22340, voclosporin 10-milligram capsules, by Lux Biosciences, Inc. The proposed indication for this new drug product is treatment of noninfectious uveitis involving the posterior or intermediate segments of the eye.

On June 17, 2008, the committee will discuss biologic licensing application (BLA) 125261, ustekinumab, a human monoclonal antibody,
Centocor, Inc., proposed for the treatment of moderate to severe psoriasis. On June 18, 2008, the committee will discuss supplemental biologic licensing application (sBLA) 10379515350, etanercept, a lyophilized powder for subcutaneous injection, Immunex Corp., proposed for the treatment of moderate to severe psoriasis in the pediatric population.

The committees will meet in joint session to be briefed on iPLEDGE, the risk management program for isotretinoin products. Presentations will provide updates on risk management activities for isotretinoin since the full implementation of iPLEDGE on March 1, 2006.

The committee will discuss what should be the necessary and sufficient safety database in order to evaluate the prescription (Rx) to over-the-counter (OTC) switch of topical corticosteroids, especially the database to evaluate the potential for hypothalamic, pituitary, adrenal (HPA) and growth suppression and other systemic and local adverse events.

The committee will discuss the following topics: (1) The effectiveness of the isotretinoin risk management program for the prevention of fetal exposure to ACCUTANE and its generic equivalents, and (2) consider whether changes to this isotretinoin risk management program would be appropriate

On September 9, 2003 the committee will discuss
Raptiva by Genentech Inc. to be used in the treatment of adults with moderate-to-severe plaque psoriasis. On September 10, the committee will discuss NDA 21-5276 Metvix by Photocure for the treatment of basal cell
carcinoma.

Biogen, Inc. announced that the U.S. Food and Drug Administration (FDA) will convene a Dermatologic and Opthalmic Drugs Advisory Committee on May 23, 2002 to review the registrational filing of Biogen's drug AMEVIVE (alefacept) for the treatment of moderate to severe chronic plaque psoriasis.

On November 16, 2000, the committee will discuss new drug application (NDA) 50-777, Protopic (tacrolimus ointment) Ointment, Fujisawa Healthcare, Inc., for short and long term treatment of the signs and symptoms of atopic dermatitis in adult and pediatric patients 2 years of age or older.

On November 4, 1999, during the morning session, the committee will discuss new drug application (NDA) 21-022, Loprox™(ciclopirox nail lacquer),Hoechst Marion Roussel, Inc., for treatment of onychomycosis.
On November 4, 1999, during the afternoon session, the committee will participate in a scientific discussion of clinical trial design questions for products intended for the treatment of hand dermatitis.
On November 5, 1999, during the afternoon session, the committee will discuss NDA 20-965, Levulan® (aminolevulinic acid HCL) Kerastick™ for Topical Solution, 20%, Dusa Pharmaceuticals, Inc., for use in the treatment of multiple actinic keratoses of the face and scalp.

On March 19, 1998, the Committee will discuss generic topical dermatologicals draft guidance. On March 20, 1998, the Committee will participate in a scientific discussion of clinical trial design
questions for products intended for the treatment of psoriasis.

On November 13, 1997, the committee will discuss new drug
application (NDA) 20-788, PropeciaTM (finasteride 1
milligram tablets, Merck Research Laboratories), for treatment of
androgenetic alopecia to increase hair growth and to prevent further
hair loss. On November 14, 1997, the committee will participate in a
scientific discussion of clinical trial design questions for products
intended for the treatment of burn wounds. This is one segment of an
overall effort by the agency to develop a guidance document on wound
healing products.

The committee will hear presentations and discuss data
submitted regarding the over-the-counter status of new drug application
(NDA) 20-834, Rogaine (minoxidil 5% topical solution), The
Pharmacia & Upjohn Co. for use as a hair growth stimulant by men with
androgenetic alopecia.

On July 14, 1997, the committee will discuss biologic
licensing application (BLA) 96-1408, Regranex (becaplermin
[PDGF-BB], Chiron Corp., in a carboxymethyl cellulose gel), OMJ
Pharmaceuticals, Inc., for treatment of chronic diabetic foot ulcers.
On July 15, 1997, the committee will participate in a general
scientific discussion regarding the development of a possible future
guidance document for chronic cutaneous ulcers. This is one segment of
an overall effort by the agency to provide guidance on wound healing
products, including a future discussion of products for treatment of
burns. The agency encourages investigators, academicians, members of
the pharmaceutical industry, consumer groups, and others with
information relevant to the topics to respond to the contact person.

On April 17, 1997, the committee will
hear presentations and discuss the teratogenicity and labeling issues
regarding approved NDA 19-821 for Soriatane (acitretin capsules,
Hoffman-LaRoche, Inc.) for use in treating severe psoriasis.

On November 7, 1996, the committee will
hear presentations and discuss the potential for neurotoxicity of
thalidomide raised by the investigational use and possible eventual
approval of thalidomide for dermatologic and other indications. On
November 8, 1996, the committee will hear presentations and discuss the
teratogenicity of thalidomide and issues of pregnancy prevention raised
by the investigational use and possible eventual approval of
thalidomide for dermatologic and other indications.

The committees will discuss data
relevant to NDA 19-501 to switch Rogaine (minoxidil 2%
topical solution, The Upjohn Co.), for use as a hair regrowth treatment
for persons with androgenetic alopecia, from prescription to over-the-
counter marketing status.

In April 1992, the Generic Drugs
Advisory Committee met to consider methods for documenting the
bioequivalence of topical corticosteroids. Subsequently, on July 1,
1992, the Office of Generic Drugs issued a guidance document entitled
``Interim Guidance for Topical Corticosteroids: In Vivo Bioequivalence
and In Vitro Release Methods.'' The purpose of the September 1994
meeting is to reexamine the 1992 interim guidance in light of new
experimental data and methods of analysis. On September 12, 1994, the
committee will discuss the pharmacodynamic (i.e., vasoconstrictor)
measurement of bioequivalence. On September 13, 1994, this topic will
be further discussed along with other issues related to the
documentation of equivalence according to the interim guidance.
Discussion will be limited to dermatologic products and will not
include ophthalmic or inhaled corticosteroid products. Also, on
September 13, 1994, there will be a review of the current status of
topics discussed at previous Generic Drugs advisory committee meetings

Upcoming Meetings

During the morning session, the committee will discuss new drug application (NDA) 206333, deoxycholic acid injection, a cytolytic drug, submitted by Kythera Biopharmaceuticals, proposed for the improvement in the appearance of moderate-to-severe convexity or fullness associated with submental fat in adults. During the afternoon session, the committee will discuss pediatric development of systemic products for the treatment of atopic dermatitis with inadequate response to topical prescription therapy.

The committee will discuss biologics license application (BLA) 125544 for CTP13,
a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab), submitted by
Celltrion, Inc. The proposed indications (uses) for this product are: (1) Reducing signs and
symptoms and inducing and maintaining clinical remission in adult patients with moderately to
severely active Crohn's disease who have had an inadequate response to conventional therapy;(2)
reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining
fistula closure in adult patients with fistulizing Crohn's disease; (3) reducing signs and symptoms
and inducing and maintaining clinical remission in pediatric patients 6 years of age and older
with moderately to severely active Crohn's disease who have had an inadequate response to
conventional therapy; (4) reducing signs and symptoms, inducing and maintaining clinical
remission and mucosal healing, and eliminating corticosteroid use in adult patients with
moderately to severely active ulcerative colitis who have had an inadequate response to
conventional therapy; (5) reducing signs and symptoms and inducing and maintaining clinical
remission in pediatric patients 6 years of age and older with moderately to severely active
ulcerative colitis who have had an inadequate response to conventional therapy;1
(6) in
combination with methotrexate, reducing signs and symptoms, inhibiting the progression of
structural damage, and improving physical function in patients with moderately to severely
active rheumatoid arthritis; (7) reducing signs and symptoms in patients with active ankylosing
spondylitis; (8) reducing signs and symptoms of active arthritis, inhibiting the progression of
structural damage, and improving physical function in patients with psoriatic arthritis; and (9)
treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis
who are candidates for systemic therapy and when other systemic therapies are medically less
appropriate.

The committee will discuss new drug application (NDA) 022225, sugammadex
sodium injection, submitted by Organon USA Inc., for the proposed indication of reversal of
moderate or deep neuromuscular blockade induced by rocuronium or vecuronium.

The committees will discuss supplemental new drug application 204275-S001,
for fluticasone furoate and vilanterol inhalation powder (tradename Breo Ellipta) submitted by
GlaxoSmithKline for the once daily maintenance treatment of asthma in patients 12 years of age
and older. The discussion will include efficacy data, but the focus of the meeting will be safety,
including the adequacy of the safety database to support approval, and whether a large safety
trial to evaluate serious asthma outcomes is recommended.

The Pediatric Ethics Subcommittee of the Pediatric Advisory
Committee will meet to discuss the general topic of how procedural
sedation for nontherapeutic (research) interventions or procedures in
the pediatric population should be considered under the Additional
Safeguards for Children in Clinical Investigations at 21 CFR 50 subpart
D. A brief summary of the subcommittee's discussion will then be
presented to the FDA Pediatric Advisory Committee on Tuesday, March 24,
2015.

The committee will discuss new drug application New Drug Application
204958, cangrelor injection, submitted by The Medicines Company, for the proposed indication
of reduction of thrombotic cardiovascular events including stent thrombosis (events related to
blood clots in a stent, a device inserted to keep the artery open) in patients with coronary artery
disease undergoing percutaneous coronary intervention (PCI). PCI refers to the opening of
narrowed blood vessels supplying the heart muscle by a balloon inserted through an artery
puncture with or without a stent.

On April 17, 2015, the committee will discuss the current knowledge regarding
the conduct of clinical studies and evaluation of clinical study data for flow diverter technology.
FDA is convening this committee to seek expert opinion on scientific and clinical considerations
relating to the study design and existing clinical studies, for flow diverter technology indicated
for the neurovasculature.

Recent Meetings

On February 27, 2015, the committee will discuss, make recommendations and vote on information regarding the premarket approval application (PMA) panel-track supplement to expand the indication for use for the Radiesse Injectable Implant (Radiesse) device to include subdermal implantation for hand augmentation to correct volume deficit in the hands. The proposed indication for use for the Radiesse device, as stated in the PMA is as follows:
The Radiesse device is for hand augmentation to correct volume deficit in the hands.
FDA has previously approved the Radiesse device for the following two indications for use: The Radiesse device is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. It is also indicated for subdermal implantation for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. The Radiesse device remains unchanged from the current FDA approved version.

The committees will discuss new drug application (NDA) 203324, for riboflavin ophthalmic solutions with UV-A irradiation, submitted by Avedro, Inc. The combination products are used in corneal collagen cross-linking and proposed to be indicated for the treatment of progressive keratoconus or corneal ectasia following refractive surgery.

On February 20, 2015, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Superion InterSpinous Spacer device sponsored by Vertiflex Incorporated. The proposed Indication for Use for the Superion InterSpinous Spacer device, as stated in the PMA, is as follows: the Superion InterSpinous Spacer (the Superion ISS) is intended to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, confirmed by X-ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion ISS is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, numbness, and/or cramping, with or without back pain. The Superion ISS may be implanted at one or two adjacent lumbar (L) levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5.